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510(k) Data Aggregation
(151 days)
The MiniMe 2 Nasal mask is intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems. It is intended for patients >2 years old and
The MiniMe 2 Nasal mask is intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems. It is intended for patients >2 years old and
The provided text describes a 510(k) summary for a medical device, the MiniMe 2 Nasal Mask, seeking substantial equivalence to predicate devices. It does not describe an AI/ML device or a study involving human readers or ground truth established by experts/pathology/outcomes data. Therefore, much of the requested information (like sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, and how ground truth was established for training) is not applicable or cannot be extracted from this document.
The document primarily focuses on demonstrating that the MiniMe 2 Nasal Mask is substantially equivalent to existing predicate devices (SleepNet MiniMe pediatric nasal mask and ResMed Kidsta Pediatric Mask) through comparative performance testing and material biocompatibility.
Here's the information that can be extracted based on the provided text, adapted to the questions where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate devices in various performance aspects. The "reported device performance" are the actual measurements for the MiniMe 2 Nasal Mask, which are then compared to the predicates.
| Acceptance Criteria (Implicitly, Equivalence to Predicate) | MiniMe 2 Nasal Mask Performance | SleepNet MiniMe Nasal Mask (K090935) Performance (Predicate 1) | ResMed Kidsta (K060105) Performance (Predicate 2) |
|---|---|---|---|
| Indications for Use: Provide patient interface for positive pressure therapy, accessory to CPAP/Bi-level, for patients >2 yo and 2 yo to 7 yo and up (MiniMe 2 aligns with SleepNet MiniMe) | |||
| Environment of Use: Home or hospital/institutional | Identical | Identical | Identical |
| Durations of Use: Single use, disposable; Single patient, multi-use (home); Single patient, short-term (up to 7 days). | Matched or represented as shorter duration which is acceptable. | Single patient, multi-use (home); Single patient, short-term (up to 7 days). | Single patient, multi-use (home); Single patient, short-term (up to 7 days). |
| Prescriptive: Yes | Yes | Yes | Yes |
| Cleaning: Soap and water | Soap and water | Soap and water | Soap and water |
| Exhalation Port: Incorporates exhalation port with multiple holes | Yes | Yes | Yes |
| Non-vented elbow: Configuration used with circuit with integrated exhalation valve | Yes | Yes | N/A |
| Delivered Pressure Range: | 4-20 cm H2O | 3-20 cm H2O | >4 cm H2O |
| CO2 washout profile (ETCO2% at mask at various pressures): Should be comparable to predicates/not excessively high. Testing done per ISO 17510-2 (largest size tested, worst case). | 4 cm H2O: 5.3 (6%) | ||
| 5 cm H2O: 5.2 (4%) | |||
| 10 cm H2O: 5.1 (3%) | |||
| Occluded: 5.3 (7%) | 4 cm H2O: 5.3 (6%) | ||
| 5 cm H2O: 5.2 (4%) | |||
| 10 cm H2O: 5.1 (3%) | |||
| Occluded: 5.3 (7%) | 4 cm H2O: 5.8 (14%) | ||
| 5 cm H2O: 5.7 (12%) | |||
| 10 cm H2O: 5.5 (7%) | |||
| Occluded: 6.8 (34%) | |||
| Dead Space: Small volume. | Small | ||
| 25 ml (Small size) | |||
| 40 ml (Large size) | Small | ||
| 21 ml (Small size) | Small | ||
| 81 ml (Large size) | |||
| Exhaust - pressure / flow: Comparable flow rates at given pressures. | 4 cmH2O: 17.1 lpm | ||
| 12 cmH2O: 33.5 lpm | |||
| 20 cmH2O: 43.6 lpm | 4 cmH2O: 19.1 lpm | ||
| 12 cmH2O: 34.8 lpm | |||
| 20 cmH2O: 45.8 lpm | 4 cmH2O: 19.5 lpm | ||
| 12 cmH2O: 36.2 lpm | |||
| 20 cmH2O: 48.7 lpm | |||
| Resistance to Flow: Acceptable resistance to flow values at various flow rates. | 30 lpm: 0.22 cm H2O | ||
| 50 lpm: 0.72 cm H2O | |||
| 60 lpm: 1.03 cm H2O | |||
| 100 lpm: 3.09 cm H2O | 30 lpm: 0.10 cm H2O | ||
| 50 lpm: 0.36 cm H2O | |||
| 60 lpm: 0.54 cm H2O | |||
| 100 lpm: 1.71 cm H2O | 30 lpm: 0.12 cm H2O | ||
| 50 lpm: 0.44 cm H2O | |||
| 60 lpm: 0.67 cm H2O | |||
| 100 lpm: 2.10 cm H2O | |||
| Biocompatibility: Materials in patient contact are identical to predicate or tested per ISO 10993. | Materials are either identical to predicate SleepNet masks or tested per ISO 10993 for specific contact types (e.g., skin and gas pathway, permanent duration) and passed respective ISO 10993 tests (e.g., Cytotoxicity, Sensitization, Genotoxicity, Implantation, Intracutaneous, Systemic Toxicity for tubing). | Defined by the predicate devices. | Not explicitly detailed for this predicate. |
| Mechanical Testing: Drop Test | Performed, but results not detailed in the summary. | Not detailed. | Not detailed. |
| Cleaning Validation: | Performed, but results not detailed in the summary. | Not detailed. | Not detailed. |
| Environmental Testing: | Performed, but results not detailed in the summary. | Not detailed. | Not detailed. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "test set" in terms of subject count. The testing performed is laboratory-based comparative performance testing (e.g., pressure-flow, CO2 washout, dead space, resistance to flow) comparing the device's physical properties to those of predicate devices.
- Data Provenance: The data is generated from laboratory testing of the physical device, not from human subject data or retrospective/prospective clinical studies. The origin is stated implicitly as SleepNet Corporation facilities (Hampton, NH, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical device performance and biocompatibility study, not one requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication by experts is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of expert ground truth. The "ground truth" for the device's performance is established by standardized engineering tests and measurements (e.g., flow meters, pressure sensors for exhaust/resistance, CO2 sensors for washout) and adherence to material standards (ISO 10993). In terms of regulatory "ground truth" for substantial equivalence, it's defined by the performance characteristics of the legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
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(44 days)
This device is intended to be used with positive airway pressure devices operating at or above 4cmH2O for the treatment of adult obstructive sleep apnea.
A nasal CPAP mask that is used with positive airway pressure equipment recommended by a physician, sleep technician, or respiratory therapist.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The provided document describes a 510(k) Premarket Notification for the iMask™ Nasal CPAP Mask. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than outright proving safety and effectiveness through extensive clinical trials for de novo approval. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of substantial equivalence to the predicate device, the SleepNet IQ™ Mask.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the characteristics and performance attributes of the predicate device (SleepNet IQ™ Mask). The "reported device performance" refers to how the iMask™ meets or is substantially equivalent to these attributes.
| Acceptance Criteria (Predicate: SleepNet IQ™ Mask) | Reported Device Performance (iMask™) |
|---|---|
| Use | |
| Intended for use in respiratory therapy | Yes |
| Intended to be used with any CPAP device | Yes |
| Indicated for single patient use in home, hospital, or sleep lab | Yes |
| Indicated for use with adult cases | Yes |
| Design/Performance | |
| Comfortable face cushion | Yes |
| 15mm swivel elbow connection | Yes |
| 3-point headstrap connection | Yes |
| Adequate venting to minimize rebreathing CO2 | Yes |
| Vent design to minimize noise | Yes |
| No latex materials | Yes |
| No sharp edges | Yes |
| Mask is lightweight (60 grams) | Yes - 64 grams |
| Polybag packaging (clean non-sterile) | Yes |
| Materials | |
| Polyurethane Housing | Yes |
| Polycarbonate & Acetal Copolymer 15mm Swivel Elbow | Yes |
| Wire Insert Molded Into Mask Housing | Yes |
| Soft Facial Contact Cushion | Yes |
| Polycarbonate 3-Point Headstrap Bracket | Yes |
| Airway & direct contact component materials meet USP Class VI standards | Yes |
| Performance Testing | |
| Meets ASTM F1054-87 & ISO 5356-1 Standards | Yes |
| Meets ISO 17510-2:2003 Standard | Yes |
| Minimum 12 lpm @ 4 cm H2O Mask Leakage To Prevent CO2 Rebreathing | Yes |
Study Proving Acceptance Criteria (Substantial Equivalence):
The "study" proving the device meets the acceptance criteria is a substantial equivalence comparison to the predicate device, the SleepNet IQ™ Mask. This is not a traditional efficacy study, but rather a demonstration that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify a "test set" in the context of clinical data for performance assessment of the iMask™ against specific patient outcomes. The evaluation is primarily a comparison of technical and material specifications against the predicate device and relevant standards.
- Data Provenance: The data primarily consists of bench testing results (e.g., meeting ASTM, ISO standards, leakage rates) and material biocompatibility testing. This is not patient-derived data in the typical sense. It is likely prospective for the iMask™'s own testing. The country of origin of the data is not explicitly stated but would be assumed to be from the manufacturer's testing facilities (Marquest Medical Products, Inc. in Englewood, CO, USA) or their chosen test labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts & Qualifications: This information is not provided and is generally not applicable in this type of 510(k) submission. "Ground truth" in this context refers to established engineering standards (ASTM, ISO), material science standards (USP Class VI), and the characteristics of the predicate device. These are objectively measurable or documented attributes, not subjective expert interpretations of clinical data.
4. Adjudication Method for the Test Set:
- Adjudication Method: This information is not provided and is not typically relevant for a substantial equivalence determination based on technical specifications and bench testing. There is no ambiguous clinical data requiring adjudication.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is used to assess the impact of a device on reader performance (e.g., radiologists interpreting images with or without AI assistance). The iMask™ is a physical medical device (CPAP mask), not an interpretive or diagnostic AI system.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, this concept is not applicable. The iMask™ is a physical medical device, not an algorithm, and doesn't operate in a "standalone" algorithmic capacity. Its performance is assessed through bench testing and material compatibility, and its intended use is with a human patient and CPAP machine.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's validation is primarily based on:
- Established engineering standards: ASTM F1054-87, ISO 5356-1, ISO 17510-2:2003.
- Biocompatibility standards: USP Class VI for materials.
- Characteristics and performance of the legally marketed predicate device: SleepNet IQ™ Mask.
- Bench test results (e.g., mask leakage at specified pressure).
8. The Sample Size for the Training Set:
- Training Set Sample Size: This concept is not applicable. The iMask™ is a physical device, not an AI algorithm that undergoes a "training phase" with a dataset.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: This concept is not applicable as there is no "training set" or AI component to the device.
In summary, the provided document details a substantial equivalence argument for a physical medical device (CPAP mask). The "acceptance criteria" are the characteristics of the predicate device and relevant industry standards, and the "study" demonstrating compliance involves bench testing and material biocompatibility assessments, not clinical trials with patient data or expert interpretation.
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